Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Validation Expert



Full Time

On Site


Indianapolis, Indiana, United States

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

The Validation Expert has responsibility for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.

Your responsibilities include, but are not limited to:

• Support site validation planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• Support site lead in maintaining the process control strategy.
• Support drafting of CSV activities for lab and manufacturing equipment.
• Supporting on going qualification activities of VHP qualification, smoke studies, temperature mapping, room qualification.
• Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation.
• Prepare and review appropriate GxP documentation including change requests.
• Identify improvement options of current processes, propose business cases

[Register to View]